年產(chǎn)1000萬片頭孢氨芐片生產(chǎn)車間的工藝設(shè)計(jì)

摘    要
 頭孢菌素的研究一直是抗菌素研究的熱點(diǎn)，每年都有新的品種被研制出來。頭孢菌素屬β-內(nèi)酰胺類抗生素，作為殺菌劑,其主要的作用機(jī)制是抑制細(xì)菌細(xì)胞壁的合成。隨著人民生活水平的不斷提高,對醫(yī)藥產(chǎn)品的需求也會越來越強(qiáng)烈,所以頭孢菌素市場潛力較大,競爭激烈,具有較好的發(fā)展前景。
 頭孢氨芐又稱先鋒霉素Ⅳ，頭孢力新，是一類廣譜半合成抗生素，具有抗菌譜廣、抗菌活性強(qiáng)、療效高、毒性低等特點(diǎn)。根據(jù)抗菌譜、對β- 內(nèi)酰胺酶的穩(wěn)定性及對革蘭氏陰性桿菌抗菌作用的不同，目前將頭孢菌素分為四代。頭孢氨芐屬于第一代產(chǎn)品，頭孢氨芐是臨床常用抗感染藥，是處方數(shù)量最大的頭孢菌素，歷年使用量也是最大的。頭孢氨芐片劑和膠囊劑都是比較暢銷的頭孢菌素類藥物。
本論文以頭孢氨芐為例，根據(jù)國內(nèi)現(xiàn)有制藥水平，進(jìn)行頭孢氨芐片生產(chǎn)工藝流程設(shè)計(jì)和其生產(chǎn)車間GMP設(shè)計(jì)，包括工藝概述、物料衡算、設(shè)備選型、車間工藝布置和設(shè)計(jì)、廠房設(shè)計(jì)、廠房人流、物流設(shè)計(jì)等，使之用于生產(chǎn)操作中。

關(guān)鍵詞：頭孢氨芐；片劑；工藝流程；車間設(shè)計(jì)

 
Annual production capacity of 10 million cephalexin tablets
workshop process design
Abstract
The  research　of antibiotics has been always focused on cephalosporin．Every year new varieties are developed．Cephalosporins are β-lactam antibiotics， as a fungicide, which of main mechanism is to inhibit bacterial cell wall synthesis．Coupled with rising living standards，demands for pharmaceutical products will be more intense，so the market potential for cephalosporins has good prospects．
Cephalexin is also known as cephalolexin．It is a kind of semi-synthetic broad-spectrum antibiotics，which has broad spectrum antimicrobial，antibacterial activity， and high efficacy， low toxicity characteristics． According to antibacterial spectrum of β-lactamase stability and antibacterial effects against gram-negative bacilli， the current cephalosporins will be divided into four generations． Cephalexin belongs to the first generation．Cephalexin is a commonly used clinical anti-infective， which is the largest number of cephalosporin prescriptions, used mostly． Cephalexin tablets and capsules are used more popular．
In this paper，according to the current level of domestic pharmaceutical，it was carried on the design of cephalexin tablet  production process and the design of its GMP workshop，including the technology overview，the calculation concerning the material balance，the selection of production equipment，plant layout and design process，the design of personal and material flow within the facilities，so that it can be used in the production operations．
Keywords: cephalexin; tablet; process; plant design

目錄
摘    要 I
ABSTRACT II
目錄 III
第一章  緒論 1
1.1 課題背景 1
1.2 頭孢菌素抗生素簡介 1
1.2.1頭孢菌素抗生素的分類及藥理特點(diǎn) 1
1.3  國內(nèi)外頭孢類藥物市場發(fā)展趨勢 2
1.3.1國外產(chǎn)品結(jié)構(gòu)、產(chǎn)量及研究開發(fā)狀況 3
1.3.2國內(nèi)頭孢菌素生產(chǎn)、品種狀況 3
1.4頭孢菌素類藥物展望 3
1.5藥品生產(chǎn)質(zhì)量管理規(guī)范(GMP) 4
1.5.1GMP的主要特點(diǎn) 4
1.5.2藥品GMP的基本條件 4
1.6 車間設(shè)計(jì)概述 5
1.6.1車間設(shè)計(jì)GMP要求 5
1.6.2設(shè)計(jì)依據(jù) 6
1.6.3生產(chǎn)規(guī)模及生產(chǎn)制度 6
第二章   頭孢氨芐的生產(chǎn)工藝流程設(shè)計(jì) 7
2.1生產(chǎn)工藝流程簡介 7
2.2各工序生產(chǎn)工藝流程 8
2.2.1配置過程 8
2.2.2中間體檢查合格標(biāo)準(zhǔn) 8
2.2.3配制流程圖 9
2.2.4壓片工序 9
2.2.5鋁包工序 9
2.2.6外包工序 11
2.3各工序要求 11
第三章  頭孢氨芐的生產(chǎn)車間設(shè)計(jì)  12
3.1物料恒算 12
3.1.1配制工序物料平衡 12
3.1.2壓片工序物料衡算 12
3.1.3鋁包工序物料平衡 13
3.2頭孢氨芐片總物料衡算 14
3.3生產(chǎn)設(shè)備選型 14
3.3.1主要生產(chǎn)設(shè)備選型 15
3.4車間工藝 18
3.4.1確定生產(chǎn)組織 18
3.4.2確定生產(chǎn)線 18
3.4.3固體制劑車間工藝布置 19
3.4.4相關(guān)工序局部設(shè)計(jì)布置 19
第四章  工程建筑設(shè)計(jì) 21
4.1采暖通風(fēng)及空調(diào)凈化系統(tǒng) 21
4.2 建筑細(xì)節(jié)的確定 22
4.3 電氣系統(tǒng) 23
4.4 給排水系統(tǒng)及工藝管線 23
4.5 環(huán)境保護(hù) 24
4.6 消防 24
4.7 參觀走廊和安全門設(shè)計(jì)說明 24
結(jié)  論 25
致  謝 26
參考文獻(xiàn) 27
附錄A 28
附錄B 31